inforMED
InjuryLZK

BINDER SUBMALAR (R)

Received Aug 4, 2021 · Event occurred Jul 22, 2021

Report 2028924-2021-00004 · MDR key 12275376

Device

Generic name

Submalar Implant

Model number

N/A

Catalog number

BSM-M

Lot number

878939

Product problems

  • Patient-Device Incompatibility

Patient

57 YR

  • Ecchymosis
  • Pain
  • Swelling/ Edema
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Ecchymosis
  • Pain
  • Swelling/ Edema
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Additional Manufacturer Narrative

METHOD: THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO IMPLANTECH, SO IMPLANTECH HAS PERFORMED ANALYSIS OF PRODUCTION RECORDS (INCLUDING STERILIZATION RECORDS) AS WELL AS PERFORMING TREND ANALYSIS. (THERE HAVE BEEN NO OTHER ADVERSE EVENT REPORTS ASSOCIATED WITH THIS MANUFACTURING LOT OR THIS STERILIZATION LOT.) RESULTS: NO DEVICE PROBLEM WAS FOUND. CONCLUSION: THOUGH THE EXACT NATURE OF THE COMPLAINT WITH IMPLANTECH'S DEVICE REMAINS VAGUE, THE EVENTS ALLEGED APPEAR TO CONSTITUTE KNOWN, INHERENT RISKS ASSOCIATED WITH IMPLANT SURGERY, AND ARE ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem

NOTE: THIS IS THE SAME PATIENT AND SAME EVENTS REPORTED IN MFR REPORT # 2028924-2021-00003. LEGAL COMPLAINT ALLEGES THAT PATIENT EXPERIENCED A VARIETY OF SYMPTOMS AFTER RECEIVING IMPLANTECH SUBMALAR IMPLANT. THE COMPLAINT CITES A NUMBER OF CONCOMMITANT THERAPIES AND PRODUCTS PERFORMED/PLACED AT THE SAME TIME. THESE WILL BE LISTED OF THIS REPORT. THE LEGAL COMPLAINT DOES NOT SPECIFY WHICH EVENTS ARE SPECIFICALLY ATTRIBUTED TO THE SUBJECT IMPLANTECH DEVICE. THE SYMPTOMS ALLEGED INCLUDE EDEMA, ECCHYMOSIS, PAIN, STIFFNESS AND SWELLING OF LIPS, AND PROBLEMS WITH THE NASAL AIRWAY, ETC. THE DEVICE WAS ALLEGED TO HAVE BEEN EXPLANTED APPROXIMATELY 30 MONTHS POST-OPERATIVELY.